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# Medical Device Human Factors Info Submission Guidance
- URL: https://www.fdaweb.com/medical-device-human-factors-info-submission-guidance/
- Published: 2026-05-28T12:00:00.000Z
- Updated: 2026-09-14T13:40:09.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5161215

FDA has published a final guidance, *Content of Human Factors Information in Medical Device Marketing Submissions*, to provide a risk-based framework to guide manufacturers on the human factors information that should be included in marketing submissions to CDRH, including 510(k)s, *de novo* requests, PMAs, and HDEs. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-human-factors-information-medical-device-marketing-submissions?utm%5Fmedium=email&utm%5Fsource=govdelivery) says the goal of a human factors assessment is to ensure that the device user interface has been designed such that use errors that occur during device use are either eliminated or reduced to the extent possible.

“The main factors to consider in a risk-based approach to human factors assessment, as described in this guidance, include the identification of (i.e., presence of or modifications to) critical tasks and the elimination or reduction of use-related risks,” the guidance says. “While FDA believes that it is optimal to minimize use-related risks as far as possible, it may not be necessary, or practical, to eliminate all use-related device risks.”

A [statement](https://content.govdelivery.com/accounts/USFDA/bulletins/41920bc?ref=fdaweb.com) announcing the publication of the guidance says that by clearly defining expectations up front, the guidance is intended to enhance predictability of the review process and support more efficient review, with agency resources focused on submissions with the highest usability risks.

The guidance contains an Introduction, Scope, Definitions, Risk-Based Approach to Human Factors Information in Marketing Submissions, Recommended Content of Human Factors Information in Marketing Submissions, Examples, and three Appendices.